asma 100 marks project
TRANSCRIPT
WELL-COME TO
1Aarti Drugs Ltd.
INTRODUCTION
Aarti Drugs Limited commissioned a new state of the art manufacturing facility for manufacturing of Active Pharmaceutical Ingredients at Plot No. E- 22, MIDC Tarapur, Tal- Palghar, Dist: Thane, 401506 State:
Maharashtra, from July 2005.
Part of the USD 265 million Aarti Group of Industries, Aarti Drugs Ltd (ADL) was established way back in in 1984.
Since its inception, the Company has established a strong presence in the Anti-diarrhea, Anti-inflammatory therapeutic groups. With its manufacturing facilities at Tarapur and Sarigam, the Company manufactures Vitamins, Anti-arthritis, Anti-fungal, Antibiotics, ACE inhibitors, besides its range in , anti-diabetic, anti-cholinergic, sedatives and anti-depressant drugs.
Over the years, the Company has been able to carve a niche for itself and is looking forward to expand the volumes. With the government initiative to encourage private health insurance schemes, consumer spending on medicines is expected to increase, which will spur growth in the generic sector in the domestic market.
The manufacturing-units of ADL are GMP certified. The Company is also in the process of acquiring an ISO 9002 compliance for all its units and one of the units has already been approved.
The Company aims at becoming the first choice of this expanding market through better products, ensuring quality and timely delivery.
This manufacturing facility is having two manufacturing plants, that have been built up in accordance with current Good Manufacturing Practices.
The plant is RCC constructed, totally closed and protected from external environment. Each manufacturing plant is a two storied building having first floor for the reaction area while ground floor for product isolation area. The plant is provided with Air Handling System, Purified Water Generation System that produces Purified water of pharmacopeial grade.
Every care is taken to avoid external and internal contamination.
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MANAGEMENT TEAMName Designation
Mr. Chandrakant V. Gogri. - Chairman
Mr. Manilal P. Savla Vice - Chairman
Mr. Prakash M. Patil - Managing
Mr. Satish P. Nachane - Managing
Mr. Harshit M. Savla Joint - Managing
Mr. Harit P. Shah - Whole time Director
Mr. Rashesh C. Gogri - Whole time Director
Mr. Uday M. Patil - Whole time Director
Mr. Shantilal T. Shah - Director
Mr. Rajendra V. Gogri - Director
Mr. Parimal H. Desai - Director
Mr. Nitin N. Prabhu - Director
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HIGH LIGHTS OF AARTI GROUP
Started in 1984 by a team of professionals.
Listed on stock exchange in 1993.
Annual turn over 90 million US dollars.
Total 8 API manufacturing units.
Regulatory Approvals such as WHO GMP certification, EU GMP,
USFDA and ISO certification in group units.
Manufacturing more than 30 products at various units.
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RESEARCH & DEVELOPMENT FOCUS
With the focus to build world-class capabilities, ADL has been successful in developing the state-of-the-art R & D Center at Turbhe near Mumbai, besides, it also have 2 In built supporting R & D Centers within our mfg. sites which all are well recognized by Department of Science and Industrial Research, Government of India , headed effectively by skilled & dedicated researchers who have successfully developed, around 30 new molecules within the past four years. Today, the Company, through its innovative and cost-effective process, is continuously developing new value added molecules.
The Strength of R & D team lies in the vast experience & knowledge they possess in the field of Chemistry / synthetic organic chemistry & testing instruments.
Starting from the process research within the labs, process optimization at kilo lab, Pilot Plant and trouble shooting during commercialization, R & D activities, synthesis, isolation, characterization of Related Substance, Reference Standards and Development of analytical methods form the main areas of work, of the Companys’ team of analytical development.
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DEFINATION OF API DRUG’S
API (Active Pharmaceutical Ingredients) means any components that is intended to furnished pharmacological activity or order direct effect in the diagnosil, cure, mitigation, treatment or preventation of disease or to affect
the structure or function of body of man or other animals.The term includes those components that may undergo chemical change in the manufacture of the drugs products & be present in the drug product in a modify form
intended to furnished the specified activity or effects.
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LIST OF API PRODUCT’S
Sr. No. Name of Product Therapeutic Category
1 Zolpidem Tartrate Sedative
2 Metoprolol Succinate Antihypertensive
3 Niacin Vitamins
4 Tinidazole Antiprotozoal
5 Ciprofloxacin Hydrochloride Antibacterial
6 Celecoxib Anti inflammatory
7 Hydroxyzine Hydrochloride Antihistaminic
8 Ticlopidine Hydrochloride Antithrombotic
9 Rivastigmine Hydrogen Tartrate Alzheimer’s treatment
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MANUFACTURING OF API PRODUCT
AS WE HAVE THE ABOVE PRODUCT’S. BUT WE ARE SHOWING THE MANUFACTURING PROCESS OF ZOLPIDEM TARTRATE. AND FOR ALL API PRODUCTS THE PROCEDURE OF MANUFACTURING REMAINS SAME.
ZOLPIDEM TARTRATE
Description :-
Zolpidem Tartrate is a solid pharmaceutical active ingredient, which is a white or almost white crystalline powder, hygroscopic.
Solubility :-
Zolpidem Tartrate is slightly soluble in water, sparingly soluble in methanol, practically insoluble in methylene dichloride.
Melting Point :-
About 196°C.
GENERAL INFORMATIONS
Nomenclature :-
Recommended International Non-Proprietary (Generic) Name (INN)
Zolpidem Tartrate
Compendial Name
Zolpidem Tartrate
Chemical Name (s)
Bis [ N, N – dimethyl – 2 – [ 6 – methyl – 2 – ( 4 – methylphenyl) Imidazo [ 1, 2 – a ] pyridin – 3 – yl ] acetamide ] (2R, 3R) -2, 3 – dihydroxybutanedioate.
Company Code Name/Number
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ZPT – For Individual BatchZT – For Blend batch
Chemical Abstracts Services (CAS) registry number
[99294-93-6]
Structure :-
Molecular Formula :
C42H48N6O8
Molecular Weight :
764.9
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2
HO2 C
CO2 H
OH
H OH
H ,
N
N
H 3C H 3C
N
O
CH3
CH 3
DESCRIPTION OF MANUFACTURING FACILITY
The manufacturing site located at the address on earlier page is spread out over an area of open plot 7800 Sq.
meters, having total open construction area 5363.20sq. Meters. The factory has two main manufacturing plants
(Plant No. I & II) and Pilot plant, Raw materials, Intermediates, finished product warehouse, Utility Building,
Q.C. Laboratory, Effluent Treatment Plant etc. The plants are well equipped with rectors pumps centrifuges.
There are adequate safety control measures. Current Good Manufacturing Practices (cGMP) are strictly
followed. Weighing scales, digital temperature indicators, pressure and vacuum gauges are there. A team of
experienced Production Officers and Executives are arranging the manufacturing process right from first stage
to the dispatched of finished product. The warehouse has separate place for storage of raw materials and
finished products. All materials are classified, properly labeled and kept at its designated places. Finished
products are quarantined and stored in separate bonded storage room.
The Quality Control Laboratory has got testing facilities and is well equipped with sophisticated instruments
like UV Visible spectrophotometer, FTIR, G.C., HPLC, TOC analyzer, Polarimeter, Autotitrator, K.F.
Apparatus, Tapped Density Apparatus and Mechanical Sieve Shaker etc.
Utility section maintains a regular supply of steam, Electricity, Chilled Water, Hot Water, Brine etc. and keeps
up the general maintenance of the factory. Trained engineers are available to attend any break down inside the
factory. Effluent Treatment Section takes care of the residue and various effluents generated during the
manufacturing processes and adhere to statutory requirements of Pollution Control Board.
The company also has a safety Department responsible for creating safety awareness at all levels. Regular
Safety and Technical audits are conducted.
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Description of manufacturing process and process control :-
Synthetic route:
CH3
N
O
OH
CH3
CH3
N
O
CH3
N
CH3
CH3
NH
CH3
CH3+
Imidazo [1,2,9 pyridine-3-acetic acid-6-methyl-2-(4-methyl phenyl)]Zolpidic Acid
Dimethylamine
POCl3
Imidazo [1,2,9 pyridine-3-acetamide N N 6 Trimethyl-2-(4-methyl phenyl)] Zolpidem Base
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Flow Chart:-
FOR MANUFACTURING OF ZOLPIDEM BASE
Sodium Bicarbonate solution POCl3
Ethyl AcetateDMA Gas
Zolpidic Acid
Ethyl Acetate Purified water
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Glass Lined ReactorK-21101 / K-21105
Addition Pot
CentrifugeCF-21101
Vacuum Tray Dryer
VTD-21101
Packing Zolpidem Base Sample to Q.C.
FOR MANUFACTURING OF ZOLPIDEM TARTARTE
Activated carbon Zolpidem Base Methanol Methanol
Tartaric Acid Solution
Methanol
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DCVD-21101Double Cone
Vacuum Dryer
FiltrationSystem
K-21107Crystallizer
K-21106Charcoalizer
CF-21103Centrifuge
MM-21101Multi Mill
FiltrationSystem
K-21106Charcoalizer
K-21108
Packing
Zolpidem Tartrate
Sample to Q.C.
Brief Process Description
Stage I : Zolpidem Base :-
4 First Ethyl Acetate is charged in reactor then further Zolpidic Acid is slowly added under stirring.
Phosphorous Oxychloride is added into the reaction mass at Room Temperature. Dimethyl amine gas is added
maintaining temperature between 100C & 250C. Further to that, Sodium bicarbonate solution is added at Room
Temperature. Reaction Mass is filtered and washed with water and Zolpidem base is dried.
Charge methanol in reactor & to this add Zolpidem base, add charcoal slurry and further maintain for half an hour at RT. Filter the slurry, filtrate is taken in another reactor, further a solution of Tartaric Acid is added into Zolpidem Base Solution, Slurry is filtered and washed with chilled methanol. Further Zolpidem Tartrate is dried.
Stage II : Zolpidem Tartrate :-
Charge methanol in reactor & to this add Zolpidem base, add charcoal slurry and further maintain for half an hour at RT. Filter the slurry, filtrate is taken in another reactor, further a solution of Tartaric Acid is added into Zolpidem Base Solution, Slurry is filtered and washed with chilled methanol. Further Zolpidem Tartrate is dried.
CHARACTERIZATION:-
Elucidation of structure and other characteristics :
I) Elemental Analysis
BASED ON THE ELEMENTAL ANALYSIS, ZOLPIDEM TARTRATE MOLECULE CONFIRMS TO CHEMICAL STRUCTURE.
Sr.No. ElementsTheoretical
valuesActual values
1. C 65. 94 % 64.38 %2. H 6.32 % 6.45 %3. N 10.98 % 10.66 %4. O 16.73 % 16.74 %
II) Ultraviolet spectrum
UV spectrum of Zolpidem Tartrate manufactured by Aarti Drugs Ltd. Batch No. ZPT/050701 and working standard Batch No. WS/2005/001 was recorded on UV-VIS spectrophotometer from 200-400 nm and the tracings are enclosed. The batch and the working standard exhibit maxima at 205 and 230 nm.
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III) Nuclear Magnetic Resonance
The proton resonance magnetic spectrum of Zolpidem Tartrate Batch No. ZPT/050701 and working standard Batch No. WS/2005/001 was recorded in deuaterated DMSO using Tetramethylsilane as an internal standard.
Sr. No.Chemical shift
(PPM)Multiplicity Assignment
1 2.90 Singlet NH-CO-R
2 3.13 Doublet O-CO-R
3 7.27 Singlet C6H6
4 7.13 Singlet C6-H3-N
5 7.27 Singlet C5-H5-N
IV) Mass Spetra
Mass spectra of Zolpidem Tartrate manufactured by Aarti Drugs Ltd. Batch No. ZPT/050701 and working standard Batch No. WS/2005/001 was recorded on mass spectrophotometer.
Sr. No. m/z
Approx w.r.t. 235
Assignment
1 235 100%
2 307 20%
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V) IR Analysis
IR spectrum of Zolpidem Tartrate manufactured by Aarti Drugs Ltd. Batch No. ZPT/050701and working standard Batch No. WS/2005/001 was taken in anhydrous potassium bromide disc. IR Spectrum of Zolpidem Tartrate sample shows pattern which is matching the theoretical requirements of FTIR. This confirms the structure of Zolpidem Tartrate based on FTIR Interpretation.
Sr.No.
Assignment
Wave number (cm-1)
Batch No :ZPT/050701
Working standard No :WS/2005/001
1. Acid Bond 3320 3318
2. Secondary Amide 1637 1637
3. Aromatic Amines 1263-1303 1264-1303
4. C-N Stretching 825 825
5. CH3-N 1401 1399
VI) XRD – Evaluation of Zolpidem Tartrate (Crystal Structure & Polymorphism)
Zolpidem Tartrate sample B. No. ZPT/050702 is compared along with working standard B. No. WS/2005/001
for XRD analysis. Zolpidem Tartrate shows Polymorphism characteristics comparable with form A. XRD
analysis was carried out at Saitec Laboratory, Vikroli, Mumbai.
Sr. No.2 Theta values of US
Patent ( No. 6242460)Sample Value (ZPT/ 050702)
1 9.00 8.882 16.10 16.203 16.60 16.484 24.60 24.52
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5 27.30 27.22
Above data it clearly shows that Zolpidem Tartrate w.r.t. patent values (US patent No. 62424601) and
Zolpidem Tartrate w.r.t product manufactured by Aarti Drugs Ltd is matching , The above x-ray diffraction
pattern found same as the prior art EP standard. Hence it concludes that, manufacturing process of Zolpidem
Tartrate followed by Aarti Drugs Ltd. is same as that of EP standard.
VII) DSC – Differential Scanning Calorimetry of Zolpidem Tartrate.
Zolpidem Tartrate sample Batch No. ZPT/050701 compared along with working standard Batch No. WS/2005/001 for DSC Analysis.
Zolpidem tartrate found complying DSC compared to working standard. DSC Analysis was carried out at IPCA Laboratories, Mumbai.
Impurity Profiling :-
Impurities present in Zolpidem Tartrate are classified as follows:
I) Related Substances
Sr. No.
Name Source of Impurity
01 Zolpidem Impurity A Process related02 Unknown Highest Impurity -------03 Total Impurities -------
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Sr. No. Criteria Patent No. (US-6242460B1) & its values.
Sample Values (ZPT/050701)
1 Endotherm 110ºC 115.21ºC
2 Exotherm 150ºC 157.25ºC
3 Melting endotherm 188ºC 186.44ºC
4 Endotherm 200ºC 203.14ºC
5 Decomposition Not Observed 230.32ºC
II) Residual Solvent
Sr. No.
Name Source of Impurity
01 Methanol Used in manufacturing process02 Ethyl Acetate Used in manufacturing process
I II) Inorganic ImpuritySulphated AshHeavy Metals
DATA RELATED IMPURITIES IN ZOLPIDEM TARTRATE :Following are the details of impurities level in Zolpidem Tartrate.
I) Related Substances by HPLC
Sr.
No. NameBatch No.
SpecificationZPT/050701 ZPT/050702 ZPT/050703
1. Zolpidem Impurity A ND ND NDNot More Than 0.10%
2.Unknown Highest Impurity
0.042% 0.016% 0.045%Not More Than 0.10%
3. Total Impurities 0.098% 0.058% 0.097%Not More Than 0.20%
Related Substances of all above batches are complying.
II) Residual solvent
Sr.
No. SolventsBatch No.
SpecificationZPT/050701 ZPT/050702 ZPT/050703
1. Methanol 131 ppm 126 ppm 119 ppm NMT 1000 ppm.2. Ethyl Acetate 14 ppm 17 ppm 64 ppm NMT 500 ppm.
Residual solvents of all above batches are complying.
III) Inorganic ImpuritySr.No.
ImpuritiesBatch No.
SpecificationZPT/050701 ZPT/050702 ZPT/050703
1. Sulphated Ash 0.05% 0.02% 0.04%NMT 0.10%
2. Heavy Metals Complies Complies Complies NMT 20 ppmSulphated Ash and Heavy Metals of all above batches are complying.
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* NMT=Note More Than* ND = Not Detected
CONTROL OF DRUG SUBSTANCE
Specification :-The specification of Zolpidem Tartrate is EP and in-house and limits given for related substances as per EP and residual solvents are as per ICH guidelines.
The test methods used for analysis of assay & related substances are exactly followedas given in EP and also are validated as per ICH Q2B guideline.
The test method used for analysis of Residual Solvents is in-house which is validated as per ICH Q2B guideline.
Analytical Method Validation :-Specification and analytical method status
Tests Method reference Validation statusAssay by HPLC In house Validated
Related substance by HPLC EP Validated
Residual solvent by G.C.H.S. In house Validated
Tartaric acid content by HPLC In house Validated
Batch Analysis :-
Analysis of 3 batches carried out as per earlier specification. Results obtained are wellwithin specification.
REFERENCE STANDARD OR MATERIALS :-
Working Standard is Prepared with comparison to Reference Material as follows:Approved batch is selected for preparation of working standard this batch is analysed with reference to official reference standard in duplicate by 2 analysts.
After comparison of result of both analysts, mean value taken for purityWorking Standard is stored in Dessicator at a room temperature. Shelf life is not exceeding 1 year.
The working standard is prepared in advance. Following tests are carried out while analysis of working standard.1) Description2) Identification by IR3) Water Content
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4) Related compound by HPLC5) Assay by HPLC
CONTAINER CLOUSRE SYSTEM
Storage Condition:Type of Material and Construction
Zolpidem Tartrate is packed in double low density polyethylene (LDPE) bags. Both the inner and the outer polybags used are made from virgin food grade polyethylene. Inner bag is natural coloured while outer bag is black coloured. Both bags are sealed individually by nylon strip having company logo engrave. This is further placed in a well /closed fiber board container and sealed with a plastic seal having serial number.
The Label :
The label bears the details of the product name, pharmacopeial specification, quantity, batch number, manufacturing date, expiry/retest date, tare, gross and net weight, drum number, storage conditions, manufacturing license number, and name and address of the manufacturer.
Packaging Material specifications :
Various packaging materials used for the packing of Zolpidem Tartrate are analysed and released prior to use.
Development Studies on Packaging Material :
These primary and secondary packaging materials were extensively evaluated for their compatibility with the Zolpidem Tartrate prior to their use.
STABILITY :-Stability Study & Methodology:
The purpose of stability evaluation is to provide evidence, how the quality of drug substance varies with time under the influence of variety of factor temperature and humidity conditions. The stability studies carried out at following different conditions.
Stability Conditions :1. Accelerated stability
condition: At 40 ± 20C & 75% ± 5% RH. (Period 6
months)2. Intermediate stability
condition : At 30 ± 20C & 65% ± 5% RH. (Period 12
months)3. Long term stability
condition: At 25 ± 20C & 60% ± 5% RH. (Period depends
on expiry period)4. Photostability condition : At 40 ± 20C & 75% ± 5% RH. (Period 1 month)
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Testing frequency :
1. Accelerated stability condition : 1, 2, 3, & 6 months.2. Intermediate stability condition : 3, 6, 9 & 12 months 3. Long term stability condition : First Year – After Every 3 months
Second year – After Every 6 months There after – Annually
4. Photostability condition : 1 month
Selection of Batches:
Process validation batches, Minimum one batch of each product per year is selected for stability study or whenever there is a change in process, material received from new vendor or any major changes in process which is affecting the quality of the final product.
Test carried out:The product under stability is evaluated fora) Descriptiob) Appearance of solutionc) Related Substances by HPLCe) Assay by HPLCd) Water Content
Stability summary and conclusion :
Sr. No. Batch Nos. Grade Remark
1
2
3
ZPT/050701
ZPT/050702
ZPT/050703
Powder
Powder
Powder
Product under stability completed 24 months Period.
Product under stability completed 24 months Period.
Product under stability completed 24 months Period.
Conclusion :
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Accelerated stability completed, product found stable for accelerated stability. Up till now 24 months long term stability completed, product found well within specification up to 24 months. On basis of available stability data of 6 months accelerated and 24 months long term, we are claiming 36 months retest period.
PRODUCTION SYSTEM
The production department works in all the three shifts and all the weekdays, each of the two plants is having
production control office situated at the junction of crude manufacturing area and pure manufacturing area. The
production activities involve.
1) DEPARTMENTAL OBJECTIVES
The production department has set following objectives for the year 2005-2006.
To establish manufacturing process for API products.
To implement and strictly adhere and guidelines of current Good Manufacturing Practices.
To manufacture the products that will consistently meet the specified quality specifications of customers, so as to ensure total customer satisfaction and regulatory compliance.
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Receipt of Raw materials from Warehouse
Execution of Batch of API and its intermediate as per established manufacturing process, which is documented
in the form of Batch Manufacturing Record
Plant House keeping and Sanitation
Sampling of intermediates and finished products
Delivery of the packed approved finished product to Warehouse
To maintain high safety standards during manufacturing of the process.
MANUFACTURING LICENCES.
Pharmaceutical Manufacturing activities are carried out as permitted by licensing authority (Food and
Drugs Administration of Maharashtra State).
Aarti Drugs Ltd is manufacturing APIs under manufacturing licence No. KD-408 &
KD-582 dated 13.07.2005.
In addition the company has been approved for WHO GMP Certificate for seven products.
MANUFACTURING ACTIVITIES CARRIED OUT ON THE SITE
Aarti Drugs Limited, E-22 is engaged in manufacturing of Active Pharmaceutical Ingredients (APIs).
These are non-sterile synthetic APIs.
This manufacturing facility is having two manufacturing plants that have been built up in accordance to
Good Manufacturing Practices. Each plant is RCC constructed, totally closed and protected from
external environment. The plant is provided with Purified Water Generation System that produces
Purified water of pharmacopiel grade and the Air Handling System. Every care is taken to avoid external
and internal contamination.
Both the plants are multi product plants. The manufacturing activity is carried out on campaign basis. A
defined procedure of product change over is strictly followed.
SHORT DESCRIPTION OF THE SELF-INSPECTION SYSTEM.
In order to verify compliance with the cGMP and ICH Q7A guidelines, regular internal inspections / audits
are performed in accordance with an approved schedule. The Self –Inspection team consists of Head –
Quality Assurance, Head – Quality Control,
Head – Production, Executive – Production and Executive – Quality Assurance. Inspection is carried out as
per schedule and report is prepared.
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Report copies are given to Vice President (Tech) and Works Manager for information and one copy is also
given to Head of Department for compliance status report indicating the corrective actions taken in timely
and effective manner.
TECHNOLOGY USED FOR PRODUCTION OF API DRUGS
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DESCRIPTION AND DETAILS OF THE SITE:
The Manufacturing facility is situated at Tarapur in the state of Maharashtra, India. Tarapur is 110 Kms
away from Maharashtra's Capital Mumbai. Mumbai is well connected to major cities of India via Rail,
Road and Air.
The total area of the plot is about 7800 Sq. Meters.
The total built up area is 2436.80 Sq. Meters
The total plot area is divided into following sections.
1. Raw material and packaging material warehouses,
2. Two dedicated and totally segregated buildings for the manufacturing activities.
3. It also has a finished goods warehouse
4. Well-equipped, self-sufficient Quality Control Laborator
5. Quality Assurance department
Facility Description - Production
A characteristic feature of the manufacturing plant is that there are two separate sections within a plant. A) Manufacturing area for Chemical Synthesis for crude product. B) Manufacturing area for Pure API.
These two areas are totally separated from one another, so as to avoid any chances of cross-contamination. Each plant is provided with separate man & material entry and exit system. Gowning procedure is being followed wherever required.
A high level of cleanliness and sanitation is being maintained in the manufacturing area.
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FACILITY QUALIFICATION & EQUIPMENT QUALIFICATION
Equipments / utilities installed have been qualified during installation, operation and performance stages.Users requirement (URS) is finalised by production and project department. According to requirement design is
prepared and approved. After approval of design, job work is given. The fabrication of equipment is done
according to approved design, any modification if required to be done is completed by reapproval of design
qualification. At the time of fabrication site acceptance test (SAT) audit is done by authorised person. After
approval of SAT the equipment is transported to factory. After receipt at factory premises factory acceptance
test (FAT) audit is done. Then equipment is released for installation qualification (IQ), operational qualification
(OQ), and performance qualification (PQ).
The equipment/ utilities are in operation for long period time without any problem or modifications in its design
since installation to produce the products consistently over the period.29
LIST OF EQUIPMENTS IN MANUFACTURING FACILITY PLANT 1
Sr. NoName of
EquipmentEquipment Code No MOC Capacity
1. Glass Lined Reactor K-21101 GLR 2 KL
2. Glass Lined Reactor K-21102 GLR 3 KL
3. Stainless Steel Reactor K-21103 SSR 2 KL
4. Stainless Steel Reactor K-21104 SSR 2.5 KL
5. Glass Lined Reactor K-21105 GLR 2 KL
6. Glass Lined Reactor K-21106 GLR 1.6 KL
7. Glass Lined Reactor K-21107 GLR 1.6 KL
8. Charcoal Slurry Vessel K-21108 SS-316 100 Lts
9. Centrifuge CF -21101 SS-316 48’’
10. Centrifuge CF-21102 SS-316 36’’
11. Centrifuge CF-21103 SS-316 48’’
12. Vacuum Tray Dyer VTD-21101 SS-316 48 Trays
13. Double Cone Vacuum Dryer DCVD-21101 SS-316 1 KL
14. Double Cone Blender DCB-21101 SS-3161 KL
15. Multi-Mill MM-21101 SS-316 50 kg /Hr
16. Sifter SF-21101 SS-316 ---
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LIST OF EQUIPMENTS IN MANUFACTURING FACILITY
PLANT NO II
Sr.NoName of
EquipmentEquipment Code No MOC Capacity
1. Glass Lined Reactor K-22101 GLR 3 KL
2. Stainless Steel Reactor K-22102 SSR 2.5 KL
3. Glass Lined Reactor K-22103 GLR 2 KL
4. Stainless Steel Reactor K-22104 SSR 2 KL
5. Charcoalizer K-22105 GLR 1.6 KL
6. Crystallizer K-22106 GLR 1.6 KL
7. Charcoal Slurry Vessel K-22107 SS-316 100 Lts
8. Centrifuge CF -22101 SS-316 48’’
9. Centrifuge CF-22102 SS-316 36’’
10. Centrifuge CF-22103 SS-316 48’’
11. Vacuum Tray Dyer VTD-22101 SS-316 48 Trays
12. Fluidized Bed Dryer FBD-22101 SS-316 120 Kg.
13. Double Cone Blender DCB-22101 SS-3161 KL
14. Multi-Mill MM-22101 SS-316 50 kg
15. Sifter SF-22101 SS-316 50 kg
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UTILITY PROFILE:-
List of Major Utility
Sr. NoUtilities Capacity
1 Purified water 1420 Lts / hr
2 AHU 7000 CFM (AC-1)9000 CFM ( AC-3)
3 Steam 4000 KG / Hr
4 Brine 15 TR @ -10 °C
5 Hot water 2 KL Storage Tank
AHU SYSTEM :-
HVAC system is provided separately for wet processing and Powder processing area.
System is always kept at positive air pressure to prevent the cross contamination.
90% circulation of air & make up with10% fresh inlet supply of air.
Temperature – Below 240C.
Humidity – Between 50 to 70 %
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PACKAGING
FIBER DRUMS :-
Description :
Cylindrical pale brown coloured fiber drums varnished from outside, with metal ring and locking system. Bottom and top lid is of hardboard and inside rough surface.
locking Strength :
Checking locking system for proper locking.
Piercing Strength :
Check once in a year for regular supplier and whenever supply is taken from a new supplier.
Storage Condition :
Keep in a clean place, away from moisture and dust.
Sampling Method :
3 drums to be checked for dimensions, locking system, weight galvanization of all metallic rings and inside finishing of every consignment.
WHITE LINER POLYETHYLENE BAGS :-
Description :
White coloured odourless plastic bags with no blemish like pin holes, scratches and doubled sealed properly on one side.
Black particles :
Black particles should be absent.
Size :762 mm x 1270 mm ( ± 15 mm) (30”x 50” )686 mm x 1168 mm ( ±15mm ) ( 27”x46” )
Weight :Between 100.0 and 130.0gms (30”x 50” )
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Between 100.0 and 130.0gms (27”x 46” )
Identification By I.R.:The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum
obtained from Liner Bag Standard.
Extractable Fraction in n- Hexane :Not More Than 5.5 % at 500c For (30”x 50” ) and ( 27”x46”)
Extractable Fraction in Xylene :
Not More Than 11.3 % 250c For (30”x 50” ) and ( 27”x46”)
BLACK LINER BAGS :-
Description :
Black coloured odourless plastic bags.
Size :
762mm x 1270 mm ( ±15mm ) ( 30”x50” ) 686 mm x 1168 mm ( ±15mm ) ( 27”x46” )
Weight :
Between 100 and 140.0gms ( 30”x50” )Between 100 and 140.0gms ( 27”x46” )
HDPE CARBUOYS :-
Description :
Oval shape wide open mouth, blue colour carbuoys with red colour lid and channel type locking clamp along with two handles.
Capacity :
20 liter
Height Width :
462 mm ± 5 mm. (Between 457 mm and 467mm.)
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Breadth :
180 mm ± 5 mm (Between 175 mm and 185 mm.)
Mouth Diameter :
50 mm ± 5 mm (Between 45 mm and 55 mm.)
Weight :
1.5 kg. ± 0.3 kg. (Between 1.2 kg. and 1.8 kg.)
PRODUCT LABEL FOR ZOLPIDEM TARTRATE :-
Product Name :
Zolpidem Tartrate EP/BP
Description :
It should be match with the label affix in product album with respect to letter style/pattern /colour complexion, Print- Storage condition/ Manufacturing License Number KD-582 Along with Aarti drugs logo and address.
Dimension :
Length 160.00 ± 3.0mmHeight 110.00 ± 5.0cmGrammage 2.660 ± 0.2gm.
Sampling Method :
Check at least 3 labels of a lot for length, breadth, weight, text matter and colour. Labels should be free of dust. Select 10 labels at a random. Take weights of 10 labels and calculate average weight.
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WAREHOUSE
This facility is having Warehouse as separate department located at ground floor of building No. 1 The Warehouse is RCC constructed, totally closed building protected from external environment. Care has been taken to avoid contamination and cross contamination.
Following are the characteristic features of warehouse.i) The warehouse department is totally closed area provided with filtered air facility.
ii) There are separate sections for storage of
a) Liquid Raw Materialsb) Solid Raw Materialsc) Packaging Materialsd) Finished Product e) Finished Product ( Narcotics Drugs & Psychotropic Substance)f) Rejected Materialsg) Hazardous Raw Materials
iii) The warehouse is also having separate areas as listed below
a) Raw material and Packaging material receipt area b) Raw material dedusting areac) Under test aread) Quarantine areae) Sampling boothf) Wash roomg) Dispensing sectionh) Exit area for dispensed raw material i) Personnel entry and change room j) Warehouse Officek) Exit area for Finished products and Packaging materials.
The warehouse is provided with adequate facilities of weighment, material transportation and material dispensing equipments.
The warehouse is provided with safety facilities like, fire extinguisher, personnel protective equipments.
In warehouse all the activities are carried out as per laid down Standard Operating Procedure, which are performed by trained and experienced employees.
Training is given to warehouse officer and warehouse in charge.
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List of Sections in Warehouse
In ware house there are basically four sections
i) Raw Material and Packaging Material receipt and sampling section ii) Section for storage of raw materials and packaging materials. iii) Section for Dispensing of raw materials.iv) Section for Storage of Finished Products
i) Raw material and Packaging material receipt and sampling section
This section is formed of following sub sections.
i) Raw material receiving bay ii) Raw Material Dedusting Areaiii) Quarantine Areaiv) Sampling Booth
ii) Section for storage of raw material and packaging material
There are separate areas for storage of
a) Liquid Raw Materialb) Solid Raw Materialc) Packaging Material iii) Section for Material Dispensing
In order to meet the requirement of production dispensing of raw material is carried out. This dispensing activity is done in separate area known as dispensing booth. The dispensing booth is having separate material and man entry. Inside the dispensing booth the facility of open front containment booth (OFCB) is provided .The OFCB facilities helps in dispensing the raw material in control environment there by avoiding chances of cross contamination. The dispensed raw material is then send to production department from designated exit area. iv) Section for Storage of Finished Products In warehouse a separate close area is provided for storage of finished product. This area is provided with the facilities of control temperature and protection from sunlight. A separate storage facilities is provided for storage of NDPS (Narcotics Drugs & Psychotopic Substance)
Further separate under test and approved areas are provided in ware house. Even there is separate area for the storage of Returned Finished Goods. In case of rejected material a separate area with proper lock and key arrangement is also
provided. Solid and liquid Hazardous raw materials have separate area
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Working Systems and Procedures
Sr. No.Description
1.Entry and Exit Procedure
2. General working System in Warehouse
3. Raw Material and Packaging Material Receipt System
4. Indent of Raw material and Packaging Material
5. Raw Material and Packaging Material Sampling, Movement and Storage
6. Issue of Raw Materials and Packaging Materials
7. Warehouse Cleaning and Housekeeping
8. Handling of Rejected Materials
9. Finished Product Dispatch System
10. Pest Control for Warehouse
Entry and Exit Procedure
In Warehouse there is restricted entry. Only authorized person are permitted for entering in warehouse.Following is the procedure for Personnel & Visitor entry and exit in warehouse area.
Procedure for Entry :-
1. Only authorized persons shall be allowed to enter in warehouse. Unauthorized person shall
accompany authorized person entering in ware house. List of authorized person is attached as
per (Annexure:01)
2. Person shall enter the warehouse through personnel entry.
3. Wear the Apron over the street clothes, put Shoes covers and head cap.
4. Enter the warehouse area.
Procedure For Exit :-
1. Exit from the Exit area to come out of warehouse remove Apron and keep it back in the space provided and dispose head cap and Shoes Cover in the waste bin.
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General working System in Warehouse
Following is the general working procedure, which has to be strictly followed while working in Warehouse.
1. Entry/Exit Procedure for man & Material, are to be followed. Practices of personal Hygiene
(Nails, Hair, Beard etc.) are to be followed strictly
2. A Good level of cleaning and House Keeping is to be maintained throughout Ware House
3. Ensure that FDV system & OFCB are working satisfactory.
4. Ensure that all balances are in calibrated state.
5. Ensure that all materials in the ware House are stored in segregated manner as well as are
appropriately labeled.
6. Personnel protective equipments are to be used whenever required.
7. All records are to be filled in time as mentioned in SOP’s.
8. Ensure that all material handling and movement devises are working properly.
9. Use cleaned containers for dispensing of Raw Material.
10. Ensure that Raw Material & Packaging Material are received and stored as per SOP.
11. Ensure that all Raw Material & Packaging Material are issued as per SOP & as per FIFO
system.
12. In case of handling finished goods follow appropriate gowning procedure.
13. In case of any abnormal observations during working report it immediately to dept head ware
house & Q.A. Dept.
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Training Programme For Warehouse :-
Training is provided to all employees of Warehouse for following areas :
a) Current good manufacturing practices and documents preparation of Warehouse .
b) Safety and handling of Hazardous Material.
c) Receipt and issue of Raw materials and Packaging materials.
d) Handling and despatch of finished product
e) Storage of Raw Material, Finished Product and Packaging material.
f) Handling of Rejected Materials.
g) Commercial and excise matters
The training is given by competent internal and external faculty. Assessment of training is also carried out.
Finished Product Dispatch Procedure :-
1. Take the sales order and verify the name of the product, specification, Grade of material quantity, party name and address and any other details.
2. Ensure that batch is properly approved by Q.A.3. Physically verify the finished goods as per finished goods transfer note given production
department. and segregate the finished product batch wise as 4. Prepare challan cum invoice while dispatching the consignment. 5. Arrange for the vehicle as per the volume of the consignment for transportation of finished
goods. 6. Inspect the vehicle and the consignment as per dispatch report attached as Annexure. Load the
finished products in the vehicle.7. Handover the original and duplicate copy of the invoice to the transporter and retain the
remaining copy with stores for record purpose.8. Make necessary entries of dispatches records as per SOP for Distribution of finished product.
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SALES
Description:
An Annual Report provides a detailed look at the financial results for the prior twelve months ofoperations. Reporting requirements vary by country, but almost every Annual Report will include:
- Chairmans Statement.- Income Statement.- Cash Flow Statement.- Balance Sheet.- Notes to the Accounts.- Auditors Report.Annual Reports may also include a marketing/product segmentation section, organizational chartsand graphs.Filing dates vary by country, as does the date by which the report must be filed by. For example,many U.S. and European companies have a year-end filing date of December 31, and their AnnualReports tend to be filed between April 1 and June 30. Japanese companies tend to file their reportduring the month of July, and Australian companies file starting September 15th.We have history as far back as 1996 for the publicly traded companies in the database.Financial filings from the Global Reports Library offer some significant benefits to researchers:- Timeliness: Using web crawler technology, proprietary tracking systems and an experienceddocument acquisition team, we are able to update 90% of the documents in our collection on thesame day they are made publicly available. For certain emerging market companies, it may take 3-5 days to source the document.- Functionality: all the documents in our collection are in full-color native PDF format, meaning thatdocuments are fully text searchable and can be copied/pasted into presentations and otherdocuments Additionally, the native PDF format means that document sizes are quite small average<2.3 MB which allows for quick downloading.- Quality: As the only Source Document collection in full color native PDF, Global Reports sets thestandard for document quality. For customers needing high resolution in order to read financialfigures or smaller font, Global Reports files are ideally suited.Obtaining Annual Reports is fast, simple, and convenient via the Global Reports Library on Researchand Markets. If you cannot find a specific Annual Report please notify us via our 'Contact Us' page.
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BRIEF ON QUALITY SYSTEM
SCOPE
Quality System establishes adequate and attainable quality standards and inspects to see that actual product meets these standards
Quality System must be alert to the opportunities and needs of the market place and must be known what customer or potential customer requires
In coordination with the individuals responsible for actual production, it should insist on the highest levels of performance, which the company’s technology permits
After standards are set, it becomes the responsibility of Quality System to see that they are met, this is
normally done through inspection of materials
Quality System attempts to determine the causes of deviations either through analysis of suppliers
weakness or Inspection of rejected materials. It is then attempts to develop methods or policies for over
coming these causes.
There must be a system for effective Quality System extents to familiarity with production methods,
materials, customer requirements, technology and product distribution.
QUALITY POLICY
To clear understanding of customers expectations and to meet quality standards accurately & Consistently.
To establish and maintain high standards of quality of its products manufactured at various locations
including those at contract manufacturing sites, meeting cGMP & cGLP norms.
To comply with current national and international regulations as applicable and continuously move
towards meeting stringent global standards.
To comply with current national and international regulations as applicable and continuously move
towards meeting stringent global standards.
Products shall be manufactured and marketed meeting all quality parameters related to identity, purity,
safety and efficacy through well defined quality assurance and validation system.
Major thrust shall be given on quality up gradation and product integrity on continuous basis to achieve
higher level of customer satisfaction.
To implement continuous training to the employees for enhancement their skills in performing their
assigned tasks.
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TEN COMMENDMENTS OF QUALITY
Quality is doing every activity right at all times.
Quality is never an accidentit is the result of itelligent planned effort.
Quality is plan to work & work to plan.
Quality is everybody’s responsibilities.
Quality beings with everybody.
Quality can not complete without “U”
Quality is pathway to progress.
Quality happens because of you.
Quality is surest way to saty in business.
Quality ensure profit, market and leadership.
DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM
RESPONSIBLE FOR MANUFACTURE .
The company shall establish and maintain high standards of Quality of its products manufactured at
various locations, meeting cGMP and cGLP norms.
Product shall be manufactured and marketed meeting all quality parameters related to identity, purity,
safety and efficacy through well-defined Quality Assurance and Validation system.
Company shall comply with current National and International regulations as applicable and
continuously move towards meeting stringent global standards.
Major thrust shall be given on Quality Up gradation and Product Integrity on continuous basis to achieve
higher level of customer satisfaction.
Continuous training shall be imparted to the employees, in the organisation to enhance their skills in
performing their assigned tasks.
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QUALITY CONTROL PROCESS :-
QUALITY CONTROL
Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting, and testing of starting materials, packaging materials, and intermediates, bulk, and finished products and
where appropriate for monitoring environmental conditions for GMP purpose.
Sampling of starting materials, packaging materials, intermediates and finished products are carried out by methods and personnel approved the quality control department.
Test methods are validated for critical tests.
Records are made demonstrating that all the required sampling, inspecting, and testing procedures have
actually been carried out and that any deviations have been recorded and investigated
Sampling & Testing of RM, PM,Intermediate and Finished Goods
Microbiological Analysis
Implementation of Good Laboratory Practices
Analytical Method Validation
Stability Studies
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The finished products complying with the prescribed specifications are only released for sale and are stored in proper container and correctly labeled.
Records are prepared for the results of inspecting and testing materials and intermediate, bulk and finished products against specifications; product assessment shall include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures.
Sufficient samples of starting materials and products are retained to permit future examination of the product if necessary;
Established, validated, and implemented all quality control procedures.
Evaluate, maintain, and store the reference standards.
Ensure the correct labelling of containers.
Ensure that the stability of the active pharmaceutical ingredients and products
Monitored.
Participate in the investigation of complaints related to the quality of the product and in environmental monitoring.
All these operations are carried out in accordance with written procedures and, where necessary, are recorded.
Facility Description - Quality Control :-
Quality Control Department comprises of four sections.
a) Chemical Laboratory .
b) Instrumentation Laboratory .
c) Microbiology Laboratory .
d) Stability Study Section .
PRODUCTION AND IN-PROCESS CONTROLS :
Manufacturing activities are carried out in accordance with laid down manufacturing
process (Master Manufacturing Formula) and strictly following appropriate Standard
Operating Procedures.
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The batch manufacturing system is briefly summarised in following flow chart;
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To make required equipments cleaned and ready for process
Receipt of Raw Material from Ware House
To ensure availability of required utilities and manpower
Area clearance of equipment in which batch is to be charged
Execution of batch as per process given in BPR
Quarantine the product for Sampling by Q.C. & analysis
Transfer of the product to approved area for further activity
To get issued blank BPR from Q. A. department
DESCRIPTION OF THE QUALITY CONTROL SYSTEM AND THE
ACTIVITIES OF THE QUALITY CONTROL DEPARTMENT.
The Quality Control Department is part of the Quality Assurance Department. It is headed by Quality
Control - Head. Finished products are tested as per Pharmacopoeial specifications along with In-house
specifications.
The major activities of the Quality Control Department are:
i. Sampling and Testing of raw and packaging materials.
ii. Testing of In-process samples.
iii. Sampling and Testing of finished product.
iv. Carrying out stability studies
vi. Testing of water samples.
vii. Microbiological Analysis
viii. Calibration of instruments
ix. Storage and evaluation of Control samples
x. Environmental monitoring.
xi. Preparation and standardization of working standards.
Trained staff, adequate facility, equipments/Instruments and validated methods are available for sampling
and testing of raw materials, packing materials and finished products.
Analytical records of raw materials, packaging materials and finished products are maintained.
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QUALITY ASSURANCE
To attain the quality objectives of the Company by instituting and implementing a system of quality assurance which ensures that :
Products are designed and developed to meet consistently the requirement of Quality, purity, efficacy, safety and stability over designated period of time.
The quality of the input material and of the finished products are defined in the form of specifications.
A production and quality control operation are clearly specified and documented and meets current Good Manufacturing Practices, Good Laboratory Practices.
There are arrangements for the supply of the correct starting and packaging materials conforming to pre-determined standards by conducting vendor audits.
All necessary controls on starting materials, intermediate products, Finished products, inprocess controls, calibrations and process validations are carried out.
Manufacturing is carried out strictly according to validated and documented procedures.
Products are not released for sale or supply before certification that the necessary authorised production and quality control procedures have been reviewed by Q.A. Department.
There are satisfactory arrangements for the storage, distribution & subsequent handling of finished products so that quality is maintained through out the shelf life.
To carry out Internal audits and self inspections in order to appraise the effectiveness and applicability of the quality assurance system.
To ensure compliance with the requirement of the Drugs and Cosmetics Rules pertaining to manufacture, testing, labelling, GMP and the pharmacopeial/ standard, test analysis & stability.
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To examine product complaints of marketed products, investigate the causes of quality defects and take appropriate measures in respect of the defective products and to prevent reoccurrence.
UNIT QUALITY ASSURANCE ORGANOGRAM :
Functions Of Quality Assurance:
Examine the specifications as per customer’s requirement.
Develop raw materials, in process and finished goods standards and specifications.
Approved specification standards.
Maintain standard samples of products, which conform authorised quality.
Develops testing methods and determine points at which inspection is required.
Recommend improved processes for products or changes in raw materials.
Manager Q.A.
Dy. Manager Q.C. / Q.A.
Q. C. Officer
Q. A. Executive
Q.C .Lab Services
Q. C. Executive
Q. A. Officer
Q.A. Services
Computer Operator
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Inspect raw materials, intermediates and finished goods for conformance with specifications
Control deviations from standard specifications/ procedures.
Assurance System
The main features of the system are :
Products are designed and developed in a manner that takes into account the basic attributes of drugs.
viz., efficacy, safety and stability, as well as the requirement of GMP and other associated
procedures.
The quality of input and conversion materials, the details of manufacture and control are documented in master documents such as Specifications, Master Manufacturing Formula and Batch Manufacturing Record etc.
Production operations incorporating the requirements of GMP ( including validation ) are
documented in the Standard Operating Procedures and Quality Assurance Procedures.
Managerial and job responsibilities of all key personnel are detailed in the ‘Organisation
Chart’.
The indenting, supply, storage and dispensing of correct starting and packaging materials are covered in the Stores documents.
Controls on materials, intermediates and finished products are carried out in accordance with
the Quality Control procedures series and other written Quality Control specifications.
Manufacturing is carried out strictly in accordance with Master Manufacturing Formula. The system of manufacturing are described in Standard Operating procedures. Manufacturing formulas and instructions are provided in the relevant master documents.
Batch records are issued to production is detailed in the Quality Assurance SOP.
Coding of input materials and end products is done to prevent any mix-up.
Area is studied with respect to civil & electrical work, Air handling system, and any other services provided, safety, Area cleanliness, and suitability for proposed implementations. If it is found suitable, it is certified as qualified and suitable for operation. The use of area is authorised by Manager Quality Assurance
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Quality Assurance Team also perform Qualification programme such as Area Qualification, equipment Qualification, that is whenever Equipment / area is newly constructed / modified or equipment received. The equipment and area qualification is done prior to usage.
Scope Of Quality Assurance :
Quality Assurance establishes adequate and attainable quality standards and inspects to see that actual product meets these standards.
Quality Assurance must be alert to the opportunities and needs of the market place and must be known what customer or potential customer requires
In coordination with the individuals responsible for actual production, it should insist on the highest levels of performance, which the company’s technology permits
After standards are set, it becomes the responsibility of Quality Assurance to see that they are met, this is normally done through inspection of materials.
Quality Assurance attempts to determine the causes of deviations either through analysis of suppliers weakness or Inspection of rejected materials. It is then attempts to develop methods or policies for over coming these causes.
There must be a system for effective Quality Assurance extents to familiarity with production methods, materials, customer requirements, technology and methods of product distribution.
Quality Assurance process
Design, Implementation & Control of GMP Systems
Vendor Qualification
Validation Studies
Product Approval, Rejection & Release
Documents Control
GMP Training
Internal Audit
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Complaint Handling & Investigation
QUALITY CERTIFICATE
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VENTILATION SYSTEM
Adequate ventilation is provided in all manufacturing, final processing and packing areas. Wherever
necessary, exhaust fans with flameproof motors are installed to improve ventilation. Separate air handling
systems are provided for
A) Final purification section
B) Final Powder processing area
C) Pure centrifuge area
D) Change rooms
E) Crude centrifuging area
F) Crude Drying area
G) Microbiology Laboratory
H) Warehouse
For final processing area, air handling systems having filtration system composed of 10, 5 and 3 micron air
filters are provided along with positive pressure and control temperature and humidity facility.
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WATER SYSTEM.
The main supply of water is through Tarapur M.I.D.C water supply system.
Two Tapings are given to M.I.D.C. water supply line for transferring the water to water generation plant.
This water is stored in RCC tank on the terrace of Plant No II which is coated with tiles from inside to
facilitate better cleaning. The water is passed through a sand filter to purified water unit consisting of
cation, anion and mixed bed followed by U. V. The purified water is then passed through Ultra Filtration
System to qualify purified water as per pharmacopial specification.
The distribution assembly and storage tanks used for purified water are fabricated with appropriate quality
of stainless steel which is electro polished to the required standards and entire system is hot water
sanitisable including Ultra Filter. The water is in loop formation and quality of water is daily monitored for
both chemical and microbiological quality parameters as per SOP. Microbial limit test is performed after
every sanitisation and regeneration programme. Water circulation and regeneration is responsibility of
production department.
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MAINTENANCE SYSTEM
Prepration of user requirement for each equipment and system.
Qualification of equipments / system.
Preventive maintenance of equipment, premises, water, HVAC systems.
Follow Good Engineering Practice (GEP) in day to day activity.
Maintenance of equipment, premises, water & HVAC system.
Follow change control and deviation system.
Taking training for up gradation.
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HYGIENE SYSTEMS
Detailed hygiene programmes should be established and adapted to the different needs within the
factory. They should include procedures relating to the health, hygiene practices and clothing of
personnel. These procedures should be understood and followed in a very strict way by every person
whose duties take him into the production and control areas. Hygiene programmes should be promoted
by management and widely discussed during training session
All personnel should receive medical examination upon recruitment. It must be the manufacturer’s
responsibility that there are instruction ensuring that health conditions that can be of relevance to the
quality of products come to the manufacturer’s knowledge. After the first medical examination,
examination should be carried out when necessary for the work and personal health.
Step should be taken to ensure as far as is practicable that no person affected by an infectious disease or
having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal
products.
Every person entering the manufacturing areas should wear protective garments appropriate to the
operations to be carried out.
Eating, drinking, chewing or smoking, or the storage of the food, drink, smoking materials or personal
medication in the production and storage areas should be prohibited. In general, any unhygienic practice
within the manufacturing areas or in any other areas where the product might be adversely affected
should be forbidden.
Direct contact should be avoided between the operators hand and the exposed product as well as with
any part of the equipment that come into contact with the products.
Personnel should be instructed to use the hand washing facilities.
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SAFETY, HEALTH & ENVIRONMENT
The chemical industries commonly handle variety of raw materials to convert them useful chemicals. At our facility we are also having process operations for creating a new wealth. During processing, handling, operating & different activities, there are some chances which may affect on daily routine work. Some Health hazards or accidents are likely to happen during activities.
Preventation of such incident with self – preparedness, safety facilities, safety procedure, training programs, emergency preparedness, first aid facilities & emergency preparedness are our key objective.
With these views, this safety manual is prepared. In chemical area, there are three main hazards.
Explosion. Fire. Release of toxic chemicals.
The identification & preventation of these hazards have been dealt in detail here.
Objectives of overall scheme of safety.
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1) To reduce exposure of personnels to chemical hazards :
Using proper equipment, piping, efficient ventillation.
Spillage, fumes, dust control methods. Avoiding built up of dangerous concentration of fumes. Use of PPE’s. Provision of personal hygiene facility like washroom, locker, work clothing, colour coding etc.
2) To minimize the unsafe – conditions :
Provision of personal hygiene facility. Proper storage, transportation & handling methods. Provision of safety instrumentation to allow safe start up & shut down. Early detection of unsafe condition. Preventive maintenance. Good housekeeping. Provision of pressure & relief system.
3) To implement planned programme for safety education & safety training
There are proper facilities for training, safety measures to the employs. It evolves safety poster, safety films, safety contents & safety suggestions which are useful to increase the interact of employs in accident preventation. Purpose of these training is to induce care in carrying out risky operations. Safety drills like hydrant drills, emergency mock drills are arranged by our team to ensure self preparedness & our ness of jobs during such situation.
We understand the fact that fulfillment of our social responsibility of contributing to a healthier society will come only if we undertake whole-herded to protect our environment and at our level, we firmly believe that a clean environment is an only basic aspect which is a pre-requisite to good health.
All system of our plant are designed so that appropriate waste-management is achieved, our systems are operated in harmony with surrounding environment & ecosystem.
We are not only having safe disposal system but also such system which can convert effluents to by product. Our in-house R & D team ensures pollution & energy conservation.
All the environment requirements are incorporated into the plant design from very preliminary stage for process.
Our eco-friend set-ups help environment to keep it clean. The features are :
Scrubber System.
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Dust Filters. ETP. AHU System.
HEALTH :
We at Aarti Drugs Ltd. are committed to best health of employees. Health of employs is in important factor in working environment.
Employs of the company are gone under regular & scheduled health check-up by medical practitioner.
Team of doctor & associate visits the company campus two times in a week at schedule time. The practitioner examines the employees having any problem related to health & required treatment is given. Inspite, medical practitioner service is for 24 hour at hospital.
Regular & scheduled plant of total health check up programme is also carried at company campus of each employee & their health status records are maintained & treatment is given immediately if any disorders found in examination.
Thus every employee is always under watch guard of medical practitioner & can work safely in the organization.
SAFETY FEATURES :
We understand our responsibility of contributing to safe-working environment for our valuable employees. At ADL we have provided all essential safety appliances, safety procedures & safety education.
Regular safety drills & safety training programmes by highly experienced persons from different industries & govt bodies make us fully prepared for preventation & control of emergency situations.
Our team is also trained certified by govt. bodies like-civil defense services for off-site emergency control. These features indicate & insure that safety readiness is our top priority.
PERSONAL PROTECTIVE EQUIPMENT (PPE) : There are two types
A) Non Respiratory.B) Respiratory.
A) Non Respiratory Personal Protective Equipment
1) Eye and face protection2) Ear protection3) Head protection
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4) Body protection5) Hand and arms protection6) Foot and Legs protection7) General protection and safety Belt
1) Eye and face protection :
Eye and face are constantly exposed to different hazards in industry Hazards like dust and mist while handling chemical, splashing of liquid while handling acid, alkali and hot and corrosive chemicals
Protecting of eyes and face from these physical and chemical hazard are of prime importance. Selection of PPE is depending upon the nature of hazard involved in process or operation.
In plant we are having two PPE for Eye and face protection
a) Safety goggle : Safety goggle is used while handling general operation in Which liquid chemical are handled.b) Face shield : face shield protect face by chemical splashes. In face and eye protection equipment important thing that lens should be transparent and complete free from flows and distortions and comfortable to wear.
Precaution while using goggle :
Make sure eye pieces are not frosted the elastic band is not loose, if visor is broken replace with new visor.
2) Ear protection :
We use two type of ear protector
i) Ear plugs.ii) Ear muffs.
Noise is major problem in industries, as it not only affect on hearing but also on nervous system by engg. means. That’s why suitable ear protection is usedear plugs and ear muffs when properly fitted and used can reduce the noise level by 30 to 40 dB
High noise level means any noise level measured on the A-weighted scale 90 dB & above
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PERMISSIBLE EXPOSURE IN CASES OF CONTINUOUS NOISE :
Total time exposure per day in hour Sound pressure level in dBA
890
6 92
4 95
3 97
2 100
1&1/2 102
1 105
3/4 107
1/2110
1/4 115
*Continous noise level for 8 hrs is 90 dBA & for 15 minutes it is 115dBA. *No exposure in excess At 115 dBA is to be permitted.
3) Head protection :
For head protection we used safety helmets.
Safety helmet is very good protection to head from injury by falling object or bodies, flying objects, overhead, spills of hot and corrosive chemicals, electric shocks etc.For protection against falling object or bodies the FRP are HOPE helmets are used because of their superior impact resistance.
PRECAUTION :
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We must wear helmets with perfect fitting the crown of helmet should be at least ¼ above the cradles the chin straps should always be used to keep helmets from falling off during normally working. Helmets should be
checked regularly for cracks and other damages suspension bands and sweat bands should be cleaned regularly once in month and should be kept away from direct heat.
4) Body protection :
Aprons (leather and rubber)i) Suits and coats (PVC)
These are made up of different material, shades, shapes and size to protect body from various hazardous like sharp object, sparks, temp., acids, alkalis, toxic and corrosive chemicals.
PRECAUTION :
Care should be taken to see that sleeves are tied properly at the wrist and gloves come over the sleeves. The length of Aprons should be sufficient enough to overlap to gumboot. Also generally working uniform should be tight fitting particularly while working on or near moving machine parts.
5) Hands and arms protection :
Protection of hands and arms is of prime importance because these part of the body are mostly employed in carrying out most industrial work, without hand protection it is impossible to carryout certain type of works.
*Selection criteria is also important while handling with different chemicals
Type of gloves Nature of chemical & otheri) Rubber (double coated) Neoprene, PVC For corrosive chemical
ii) Nitrile Rubber Hydrocarbonsiii) Butyl rubber Oxidized chemicals &ketonesiv) Asbestos Hot working environmentv) Ordinary rubber hand gloves For general purpose vi) Surgical hand glove To avoid direct touch from final product
or intermediate
6) Foot and legs protection :
Foot injuries are generally caused by falling objects while handling, heavy material, drums, etc. by tripping from nails, sharp objects, chemical etc. safety foot wear available in different type and style.
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The common type of safety shoes are generally with leather or rubber or PVC sole and having reinforced metal toe cap which protects the toes against falling objects, accidental kicking sharp object etc.
Depending upon the hazards the sole may be different material for effective protection for working with acid, alkali’s and other corrosive chemical, shoes with molded rubber sole will give limited protection for protection against splashes and sprays, rubber, and PVC gum boots are be used.
Gum Boot : Gum boot with steel toes are recommended, where hazards from falling, bodies as well as chemical are present.
7) General protection (safety belts with lifeline) :
For working at heights, pits or other confined places or underground operation safety belt with lifeline should be used safety belt is nothing but generally cotton webbing. Lifeline should be ¾ inch dia (manila rope) or ½ inch dia nylon rope lifeline is secured above the point of operation to a structural member which is capable of supporting required load.
PRECAUTION :
i) The waist belt should always be inserted through D ring or other attaching device and never be riveted to them.ii) Belt and lines must be inspected before use and immediately after use under corrosive condition.iii) Leather belt must be specially watched for cuts or scratches and also fabric belt for wear and tear.iv) Check hook for damage.
LIST OF PERSONAL PROTECTIVE EQUIPMENTS
A. Respiratory.B. Non Respiratory.
A. Respiratory.
a. Cartridge Respirators.b. Air line Respirators.c. SCBA.
B. Non Respiratory.
a. Helmets.
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b. Earmuff, plugs.c. Chemical splash goggles.d. Face shield.e. Flexible rubber goggles.
f. Dust mask.g. PVC approns.h. Hand gloves (rubber, acid alkali proof, leather, PVC electrical, surgical, asbestos, Nitrile)i. Safety shoes.j. Safety belt.
GUIDE LINES FOR EMERGENCY CONTROL
In case of extreme emergencies in chemical plants, emergency procedures to shut down and evacuate the plant should be well defined and drilled into personnel. Essential staff and their duties are designated and non-essential staff should be evacuated from site. Authorized personnel co-ordinate work along with one in overall charge.
We are having aims of our emergency control plan.
a. To minimum loss of life and property of plant as well as adjucent environment.b. To avoid confusion and handle the emergency with straight action. c. To alert the neighborhood.d. To safe guard non affected areas.e. To save records.f. To ensure safety before resume the work.
We are having team of key personals specially assigned with specific work they are:
a. Chief controller.b. Site controller. c. Liaison officer.
Emergency Guidelines :
1) When an emergency occurs, the person who observes it should inform about the emergency to the chief controller / side controller / Shift in charge / Security in charge.
2) He confirm the message assesses situation and immediately report to the emergency control center and alert the factor personal through whistling siren.
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3) Emergency location and assembly point will be declared form control center.4) Chief controller will take charge of situation and evaluate hazard.5) Chief controller will also make arrangement for civil work, electric work and engg work, shut down etc.6) He also inform the liaison officer and all team leader will be in contact with him.
7) Chief controller is having final authority in this operation he will take decision about fire fighting, rescue operation, calling outside agency for help, welfare etc.
8) Shift in charge, security in charge will act as a chief controller and carry out necessary activities till the chief controller or side controller reaches to the site.
9) Site controller will arrange for fire fighting and rescue operation and guide their team leader he will also arrange PPE required and maintain record of incidence and activities.
10) Only liaison officer will inform to internal or external agencies about emergency no other person supposed to talk to anyone about emergency to avoid confusion.
11) After confirmation of emergency location from the emergency control center, concerning teams will start functioning, Team leader will communicate with emergency control center and their team members.
GUIDELINES FOR HANDLING CHEMICALS 1) For Solvent Handling :
A) Use PPE as per requirement.B) Check scrubber system before operation whenever necessary.C) Aware the production personal familer with all key properties like nature of solvent,
flammability, solubility, stability, toxicity of particular solvent.
D) Check for all safety measure and equipments like extinguisher, hydrant system, first aid facility are ready.
E) Check for proper earthing and bonding whenever solvents is flowing through pipe lines, discharging from one tank to another tank, while charging or unloading solvent
F) Check for jumper when solvent is flowing through line.G) Use nitrogen blanketing whenever necessary or for purpose of vacuum breaking.
2) Corrosive Chemical Handling :
A) Use PPE as per requirement for acid, alkali B) Check for handling containers we use the container or bucket to be used of plastic or PVC,
HDPE etc (suitable for specific material or chemical to be handle)
C) Avoid vapour formation in plant as the vapour are corrosive for equipment also for working person so scrubber system is provided, always keep ready on condition.
D) When contact with any corrosive material with any part of body, wash with plenty of water about 15 minutes and seek for first aid and refer to doctor if required.
E) In case of some spillage of acid or alkali flush with water and immediately clean and in case of
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inhalation problem shift person in fresh air.
3) Toxic Chemical Handling :
A) Handle the toxic chemical with proper care.B) Handle in closed container.C) Prevent from exposure to direct sunlight.D) Use recommended PPE.
FIRST AID
Although in factories sufficient measures are taken to minimize accident but accident can not be avoided and hence we are having proper first aid facilities for common accidents such as heat, fire, smoke, cuts etc. For our employees a first aid box provided in the charge of a responsible person who is in working hours and trained in first aid to institute adequate precautionary and prompt first aid for employees. We are fully equipped for first aid to the persons who are in need for it.
Objectives of our first aid facility:
1) To save the life of casualty.2) To prevent further complications.3) To give comforts to the casualty.
Knowledge of first aid is useful: for our employees it is essential & useful not only in working place but also,
1) Road accident. 2) Sports accident.3) Industrial accident.4) Household accident.5) School accident6) War.7) Natural calamities.
We are having good quality first aider having skills :
1) Good knowledge of first aid.2) Boldness3) Power of quick decision4) Sympathetic attitude to the patient5) Ability to handle to crowd.6) Good power of observation.
First aider always remember :
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1) Always explain to casualty what you are going to do for him.2) Give satisfactory, positive and honest reply to question asked by casualty and if you really do not know the
answer please say so.
3) You must wash your hands thoroughly before and after going first aid.4) Clean and wash off splashed blood with soap and water as possible use disposable gloves while giving first aid Giving first aid can some time be dangerous so always remember to protect you do not put your life to risk having a real emergency situation can be very stressful where you may feel upset move worried or guilty these feeling are but natural try to your friend, parents or doctor and open up the mind.
EXAMINATION OF CASUALTY :1) Take detail history of disease.2) Examine the casualty from head to foot.3) Come to conclusion and diagnosis.4) Give him the first aid treatment.5) If necessary transfer him to hospital.But an emergency can happen any where and any time so you need to act very quickly In emergency situation the above steps to be modified so follow to planned action of DRABC to examine the serious casualty.
Basic steps to manage an emergence situation. D: dangersR: check response of the casualtyA: open the air B: check breathing look, listen, feelC: check for circulation Detail head to foot examination of the casualty is to be done Keep the casualty in recovery position if the casualty is breathing and unconscious Call for doctor
FIRST AID BOX AND LISTAn ideal first aid box must contain the following thing
1) Gauze, preferably sterilized for dressing
2) Cotton for dressing
3) Triangular bandage 6for emergency bandage
4) Roller bandages (1,2,3 inch) 1 dozen for dressing
5) Antiseptic savlon, dettol, hydrogen peroxide etc
6) Antibiotic oinment Soframycin
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7) Splints of various sizes to immobilize the fracture
8) Eye wash glass to remove foreign body in the eye
9) Tab. Paracetamol for fever, body ache etc (2 × 10 = 20 tabs)
10) Tab colegesic for pain in the abdomen
11) Vicks Vaporub for cold & flue (20 gm. 1 No)
12) Band aid to cover wound (20 Nos)
13) Burnol antiseptic (1 No)
14) ENO for gastro intestinal (2 Nos)
Safety Guidelines
1) Guidelines for Use of PPE
2) Guidelines for Handling of Chemicals
3) Guidelines for Handling of Fire Fighting Equipments
4) Guidelines for Accidental Preventation
5) Guidelines for Emergency Control
6) Guidelines for First aid
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HR DEPARTMENT
Appointment qualified staff.
Training for up gradation from outside.
Training , discipline, rules & regulation.
Maintain staff wale fare facilities to employee.
Annual medical checkup & provide weekly medical service for each employee.
Performance approval system & annual increment.
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WORKING OF HR DEPT.
General Administration
Recruitment & Selection
Induction Programme
Induction Programme
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Periodic Health Checkup
Training & Development
MILESTONES
1984 Aarti Drugs Limited (ADL) was incorporated. ADL has spread its exports to over 65 countiesworldwide since its inceptions.
1987 The Company started its commercial production with the aid of Gujarat State FinanceCorporation and Gujarat Industrial Investment Corporation.
1989-2001The Company has achieved merits in export performances which are marked by Certificates ofMerits from Chemexcil in the year 1989-90, 1991-92 and 2000-01.
1996 The Company has been awarded Government Recognized Export House status.
2001 ADL was also voted as the Best Vendor by OPPI. (Organization of pharmaceuticals Producers ofIndia) for the year 2001
2002-03 ADL has initiated R&D activities in its Tarapur Plant and set up R&D centre at Turbhe in NaviMumbai.
2003-04 Increased the bulk drug installed capacity by 588000kg thus total capacity has increased by18018000 Kg.
2004The Company bags European certification for three drugs. It, in fact, enjoys market leadership ineight out of its fifteen principal products.It has recently filed a patent patent for a dihydrochloride of Levocetirizine, a famous molecule intherapeutic segment for treatment of allergy.ADL has also filed applications for USFDA approvals for six new molecules in differenttherapeutic segments such as anti-diarrhoea, cardiovascular, anti-diabetic, sedatives and antidepressant.
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RESEARCH METHODOLOGY
The various means & methods have been desployed for effective collection of the desired data has been elucidated in this section.
MEANING:
Research methodology means which is carried out study the problems. It shows the type of sample design used its size, & the procedure used to draw a sample, it also includes focus on method used to collect data, process of filtering & analyzing the data.
RESERCH:
Online search.
Personal contact with the companies staff.
Personal interview with companies member.
Data collected from the profile of the company.
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CONCLUSION
Drug abuse is a complex problem thought to result from a combination of hereditary, psychological, and
environmental factors. It affects people from the neonatal stage to old age. Infants of abusers may suffer from
neglect or the effects of parental drug use. As they grow into childhood, they may demonstrate antisocial
behavior, and signs of malnutrition, poor self-esteem, depression, or attention deficit disorder. This may lead an
adolescent to use drugs, have unwanted pregnancies, and drop out of school. Identification of drug abuse is a
difficult first step on the road to recovery because of the methods many abuses use to hide their addiction, the
inability of family members to recognize or accept the problem, and the relatives' enabling behavior.
Oral health care professionals, have an ethical responsibility to inform patients of how drug abuse can damage
their health. With increased knowledge of chemical dependency, one may be able to identify and encourage a
patient, co-worker, or family member to seek the support needed to change substance abuse habits. The self-
assessment checklist and list of resource may provide insight and information helpful to someone who must
take that difficult first step to recovery.
Requiring that foreign facilities meet the same quality standards as EU and US plants, will not, in and of itself,
assure that regional/national security is maintained, but rigorous enforcement of the same standards across all
pharmaceutical production venues will at least slow the departure to locales where a lack of enforcement results
in a lower cost of doing business and a higher risk to the health and safety of EU and US citizens.
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